INDICATIONS

DOSAGE AND ADMINISTRATION

The contents of one single use container (deliverable
volume: 0.25 mL) should be instilled into the affected ear twice daily
(approximately 12 hours apart) for 7 days.

Wash hands before use. The solution should be warmed, by
holding the container in the hands for at least 1 minute, to minimize the dizziness
that may result from the instillation of a cold solution into the ear canal.
The patient should lie with the affected ear upward and then the solution
should be instilled. This position should be maintained for at least 1 minute
to facilitate penetration of the drops into the ear. Repeat, if necessary, for
the opposite ear.

HOW SUPPLIED

Dosage Forms And Strengths

CETRAXAL is a sterile, preservative-free, otic solution of
ciprofloxacin hydrochloride quivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25
mL) in each single use container.

Storage And Handling

CETRAXAL (ciprofloxacin otic solution) is a clear, colorless, sterile, preservative-free
solution. CETRAXAL (ciprofloxacin otic solution) is supplied as a 0.2% otic solution in a low-density polyethylene
(LDPE) single use container. Each single use container delivers 0.25 mL of solution
equivalent to 0.5 mg of ciprofloxacin; 14 single use containers are packaged
in a foil overwrap pouch in a carton (NDC 66992-450-14).

Store at 15°C to 25°C (59°F to 77°F). Discard used
containers. Store unused containers in pouch to protect from light.